{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2013-04060", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131004", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110330", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131007", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "502670", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131004", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000, A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20131004", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "31 YR", "patient_sex": "", "patient_weight": "77", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Abdominal Pain", "Adhesion(s)", "Granuloma", "Hemorrhage/Blood Loss/Bleeding", "Necrosis" ] } ], "distributor_city": "", "date_report": "20130905", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3388882", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130905", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "18759048", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. ON 10/02/2013, ISI SPOKE WITH THE SITE'S RISK MANAGEMENT GROUP CONTACT. SHE CONFIRMED THAT THEY DO NOT HAVE ANY REPORTS OF ANY ISSUES WITH THE DA VINCI SYSTEM INVOLVING THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL HYSTERECTOMY PROCEDURE." }, { "mdr_text_key": "18470338", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION AND MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE HYSTERECTOMY OPERATIVE REPORT, THE PATIENT'S PREOPERATIVE AND POSTOPERATIVE DIAGNOSES WERE NOTED AS MENORRHAGIA. THE OPERATIVE REPORT INDICATED THAT THE PATIENT'S UTERUS WAS NORMAL IN SIZE AND THE OVARIES WERE COMPLETELY NORMAL BILATERALLY. AFTER THE UTERUS WAS REMOVED VAGINALLY, ALL PEDICLES WERE INSPECTED. HEMOSTASIS WAS NOTED AND BOTH URETERS WERE FOLLOWED FROM THE PELVIC SIDEWALL. THE PATIENT'S URINE WAS DRAINING ADEQUATELY AND CLEAR. NO COMPLICATIONS WERE NOTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON (B)(6) 2011. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ON (B)(6) 2011 (APPROXIMATELY 3.5 MONTHS AFTER THE DA VINCI HYSTERECTOMY PROCEDURE), THE PATIENT HAD COMPLAINTS OF VAGINAL BLEEDING AND ABDOMINAL PAIN AFTER INTERCOURSE IN THE MORNING. THE PATIENT WAS TRANSPORTED TO THE DOCTOR'S OFFICE AND THEN TO THE EMERGENCY ROOM VIA AN EMERGENCY MEDICAL SERVICE. WHEN SHE ARRIVED AT THE EMERGENCY ROOM (ER), HER ABDOMINAL CT SCAN RESULTS WERE UNREMARKABLE. ON (B)(6) 2011, THE PATIENT HAD LAPAROTOMY PROCEDURE, LYSIS OF ADHESIONS, AND SUTURING OF VAGINAL CUFF FOR VAGINAL CUFF DEHISCENCE. ACCORDING TO THE OPERATIVE REPORT, THE VAGINAL CUFF WAS NOT BLEEDING; HOWEVER, IT WAS DEHISCED ALL ALONG ITS LENGTH. THERE WAS ALSO A SMALL AMOUNT OF NECROTIC AND GRANULATION TISSUES IN THE MID PART OF THE CUFF CLOSE TO THE RECTUM. THE PATIENT WAS DISCHARGED ON (B)(6) 2011. NO OTHER MEDICAL RECORDS WERE PROVIDED RELATED TO POST OP COMPLICATIONS. THE PATIENT'S CURRENT CONDITION IS UNKNOWN." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }